Author of

• 25859

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  OA08 - Mesothelioma: Immunotherapy and microRNA for Diagnosis and Treatment (ID 907)

  • Event: WCLC 2018
  • Type: Oral Abstract Session
  • Track: Mesothelioma
  • Presentations: 1
  • Moderators:
  • Coordinates: 9/24/2018, 15:15 - 16:45, Room 201 BD

  • 25860

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    OA08.01 - Long-Term Efficacy and Safety of Nivolumab in Second- or Third-Line Japanese Malignant Pleural Mesothelioma Patients (Phase II: MERIT Study) (ID 11833)

    15:15 - 15:25  |  Author(s): Mitsuhiro Takenoyama
    • Abstract
    • Presentation
    • Slides

    Background
    

    Malignant Pleural Mesothelioma (MPM) is a rare and highly aggressive malignancy with poor prognosis and no treatment is approved for patients (pts) progressing after 1st line pemetrexed-platinum doublet. Here, we report latest analysis of MERIT study in previously treated Japanese MPM pts to update the previous report (WCLC 2017, Goto Y, et al).

    a9ded1e5ce5d75814730bb4caaf49419 Method
    

    This open-label study enrolled advanced or metastatic MPM pts previously treated with up to two regimens of chemotherapy including pemetrexed-platinum doublet. Enrollment criteria also included histologically-confirmed, unresectable MPM without prior surgery, measurable lesion and ECOG performance status 0-1. There was no restriction of PD-L1 status. Pts received Nivolumab 240 mg flat dose Q2W until progression or unacceptable toxicity. Primary endpoint was objective response rate (ORR) (modified RECIST by independent review committee, expected response rate was 19.2%); secondary endpoints included disease control rate (DCR), duration of response (DOR), progression-free survival (PFS), overall survival (OS) and safety.

    4c3880bb027f159e801041b1021e88e8 Result
    

    Thirty-four pts received Nivolumab in this study. Males: 85.2%, median age: 68.0 years (range 43-78), PS 1: 61.8%, epithelial/sarcomatoid/biphasic: 79.4%/8.8%/11.8%, 1 prior regimen: 70.6% and PD-L1 (≧1%)/PD-L1 (<1%)/not evaluable: 58.8%/35.3%/5.9%. At a median follow-up of 16.8 months (range: 1.8-20.2), ORR was 29.4 % (n=10, 95%CI: 16.8-46.2). DCR was 67.6% (n=23, 95%CI: 50.8-80.9). Median DOR was 11.1 months (95%CI: 3.5-16.2). Median PFS was 6.1 months (95%CI: 2.9-9.9) in all pts, 7.2 months (2.8-15.0) in PD-L1 (≧1%) and 2.9 months (1.4-9.3) in PD-L1 (<1%). Median OS was 17.3 months (95%CI: 11.5-NR) in all pts, 17.3 months (8.2-NR) in PD-L1 (≧1%), 11.6 months (5.8-NR) in PD-L1 (<1%), across tissue types, 15.7 months (95%CI: 8.0-NR) in epithelioid and not reached in sarcomatoid/biphasic pts. Six- and 12-month survival rates were 85.3% (95%CI: 68.2-93.6) and 58.8% (95%CI: 40.6-73.2). Twenty-six (76.5%) pts experienced treatment-related adverse event (TRAE), and 11 (32.4%) experienced grade 3/4 TRAEs. Most commonly reported TRAEs were skin disorder (n=6, 17.6%), elevated lipase (n=5, 14.7%), elevated amylase and diarrhea (n=4, 11.8%). Four pts required dose discontinuation because of interstitial pneumonia (n=2, grade2 and 3) and pneumonitis (n=2, grade3).

    8eea62084ca7e541d918e823422bd82e Conclusion
    

    Nivolumab shows durable long term efficacy and manageable safety profile in Japanese 2nd/3rd line MPM pts.

    6f8b794f3246b0c1e1780bb4d4d5dc53

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• 25955

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  P3.01 - Advanced NSCLC (Not CME Accredited Session) (ID 967)

  • Event: WCLC 2018
  • Type: Poster Viewing in the Exhibit Hall
  • Track:
  • Presentations: 1
  • Moderators:
  • Coordinates: 9/26/2018, 12:00 - 13:30, Exhibit Hall

  • 27432

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    P3.01-76 - Clinical Background and Response to Chemotherapy in NSCLC Patients with MET Exon14 Skipping Mutation or High MET Gene Copy Number (ID 12850)

    12:00 - 13:30  |  Author(s): Mitsuhiro Takenoyama
    • Abstract
    • Slides

    Background
    

    MET exon14 skipping mutation (SM) and high gene copy number (HGCN) are present in 3-4% and <1% of NSCLCs. The response to MET inhibitor treatment has been reported in ongoing clinical trials; however, the response to chemotherapy, including immunotherapy, is currently unknown. We conducted a retrospective analysis of patients with MET gene alteration.

    a9ded1e5ce5d75814730bb4caaf49419 Method
    

    We collected the clinicopathological data of NSCLC patients with MET gene alteration. The response to chemotherapy was evaluated according to RECIST v1.1.

    4c3880bb027f159e801041b1021e88e8 Result
    

    Systemic chemotherapy was given to 10 patients: SM (n=5) and HGCN (n=5). The median age was 67.5 (range 41- 77) years. Thirty percent of the patients were female and 40% were never smokers. The most common histology was adenocarcinoma (40%), followed by pulmonary sarcomatoid carcinoma (20 %). The tumor PD-L1 expression was >50% in 57% (4/7) of the cases and 1-49% in 43% (3/7) of the cases. Platinum doublet, MET inhibitor, immunotherapy (I-O), and I-O+chemotherapy were given to 6, 8, 2 and 1 patients. The overall response rate was 50%, 83%, 0% and 100%, respectively. Hyper-progressive disease after immunotherapy was observed in one patient with SM.

    8eea62084ca7e541d918e823422bd82e Conclusion
    

    The responses to platinum doublet and MET inhibitor treatment were good, while the response to immunotherapy was poor in NSCLC patients with MET gene alteration. MET gene alterations should be identified before the administration of immunotherapy.

    6f8b794f3246b0c1e1780bb4d4d5dc53

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